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TerminatedNCT01050283Updated Jul 27, 2015

A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)

A Phase 1 interventional study of Comparator: [18F]-FDG PET/CT and Volumetric CT in Advanced Pancreatic Adenocarcinoma, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2015-07-27.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
35 Years and older
Sex
All
01

Study summary

This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.

02

Conditions studied

  • Advanced Pancreatic Adenocarcinoma

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Keywords

  • Advanced pancreatic adenocarcinoma
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 15 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
  • Patient is scheduled to receive standard chemotherapy containing gemcitabine
  • Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
  • Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution

Exclusion criteria

Exclusion Criteria:

  • Patient has had open abdominal surgery within 6 weeks of the screening visit
  • Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
  • Patient has an active infection, inflammation, or unresolved bowel obstruction
  • Patient has poorly controlled diabetes
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    1

    \[18F\]-FDG-PET/CT (Computed Tomography) Imaging

    Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT

Interventions

  • ProcedureComparator: [18F]-FDG PET/CT and Volumetric CT

    Patients will receive gemcitabine-based therapy as prescribed by their treating physician. FDG-PET/CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. Volumetric CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy.

06

What researchers measure

Primary outcomes

  1. Association of changes in FDG uptake with overall survival (OS)

    Time frame: Week 3 and at least 7 months after the last patient is treated

Secondary outcomes

  1. Association of metabolic response with OS

    Time frame: Baseline, Week 3, and at least 7 months after the last patient is treated

  2. Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7

    Time frame: Week 3 and Week 6-7

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01050283
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jan 15, 2010
Start date
Jul 2010
Primary completion
May 2012
Completion
May 2012
Last update
Jul 27, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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